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Re: vator post# 581490

Wednesday, 03/29/2023 2:50:22 PM

Wednesday, March 29, 2023 2:50:22 PM

Post# of 705436
You kidding me, right? They have not even applied to EU, FDA, or Canada. We get UK approvals this year, but I don’t expect any other approvals in 2023. Even when they are done with various RA applications and are close to approvals in 2024, you will realize how much they are going to struggle getting reimbursements sorted in Europe, provided you are still invested in this company! It will take couple of years to cover EU reimbursement with this team, mark my words! And it doesn’t get easier. The scaling of commercial operations will require significant investment and time. They haven’t invested in personnel yet. Furthermore, quality control becomes a huge burden because FDA and European agencies will be frequent visitors! They have literally no experience in any of these areas. There will be multiple fumbles along the way and you end up wasting years of exclusivity. And that’s not all, there will be many other competitive dynamics in play once they do get approved.

By the way, LG and other senior executives will be in their 80s, LP in her 70s before they complete a trial of any other indication outside GBM. And who knows whether the data will be positive or they mess up the trial design or some other aspect again!
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